
Pentron Ceramics, Inc.
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AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN is an FDA 510(k)-cleared medical device (K070699) manufactured by Pentron Ceramics, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2007. Regulation: 8.